ABSTRACT

A highly sensitive method for the quantification of genotoxic impurity Ethylbenzene sulfonate (EBS) in Amlodipine Besylate using hyphenated techniques has been developed. EBS is assessed by LCMS/ MS method in selected ion monitoring mode (SIM) using Shodex C 18 (150×4.6mm) 5.0 ?m column. 0.01M ammonium acetate is used as buffer and its admixture with acetonitrile in the ratio: 60:40 (v/v),is found to be an effective mobile phase A and with the buffer and acetonitrile in the ratio: 5:95 (v/v) as mobile phase B. The gradient program (T/%B) is set as 0/5, 2.00/5, 4.00/50, 8.00/70, 10.00/95, and 15.00/95. The developed method has been validated as per International Conference on Harmonization guidelines. The LOD and LOQ values of EBS are found to be 0.01 ?g/mL and 0.04 ?g/mL respectively. Method has accuracy within 98.1 – 103.0% for the analyte. This method is costeffective, direct, accurate and convenient quality control tool for determination of EBS in Amlodipine Besylate. Keywords: Amlodipine besylate, Ethyl benzene sulfonate (EBS), genotoxic, Selected ion monitoring (SIM)
Publication date: 01/05/21

https://ijbpas.com/pdf/2021/May/MS_IJBPAS_2021_5452.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.5.5452